The Demystifying regulations and commercialisation mini-series was hosted through the Christabel Pankhurst Institute for Health Technology Research and Innovation. The mini-series consisted of four events, taking place between June and October 2021, organised by Advanced Materials in Medicine (AMM), Translation Manchester, Digital Futures, the University of Manchester Innovation Factory, and the Institute of Data Science and AI.

Click on the each event title below to view the recording on YouTube.


Translating AI into Clincial Practice (29th June)

Led by the Institute of Data Science and AI, the goal of this workshop was to provide an overview of some aspects of current thinking in this area with a range of key stakeholders, along with a panel discussion.
The event welcomed 68 participants, including researchers in the areas of digital health and AI, AI Developers, Health Data Informaticians, Health Data Scientists, Clinically-qualified researchers/practitioners, SMEs, Regional development leads and non -traditional audiences who might be exploring entering this sector. Participants were also welcomed from across GM academic, industry, NHS and government-linked organisations.
Speakers included; Professor Alastair Denniston and Dr Xiao Liu, University Hospitals Birmingham speaking about AI Clinical Trials: CONSORT-/SPIRIT-AI; Johan Ordish (MHRA) speaking about AI Regulation; Dr Mireia Crispin Ortuzar (Cambridge) speaking about Emerging Evidence; and Dr  Paul Bromiley (NHS AI in Health and Care Award Panel Chair).


Digital Health Technologies regulatory event (1st July)

Tieing into the Manchester Connected Health Ecosystem, this event welcomed 45 participants, including world leading academic expertise, businesses, Health and Social Care professionals across the NHS, Public Health and local government, and patient and service user representatives.
Richard Hall from QMS Consultancy Ltd hosted a Medical Device Regulatory Clinic. Richard shared his experience by defining what it takes to gain Regulatory Compliance for MD’s, IVD’s and Stand-Alone MD Software (SaMD).
Four meetings with Richard were arranged following the session for an assessment of a specific technology or device. Two of these were ERDF SMEs.


Medical Technology regulatory event (2nd September) 

This event welcomed 28 participants, including researchers, academics, clinicians, ERDF SMEs and healthcare providers.
Kyun Thibaut, owner of COVARTIM, is a regulatory expert in the field of Medical Devices. In his presentation and Q&A, Kyun covered the European Landscape, the EU regulatory pathway for medical devices and comparison with the US. Free 1-2-1s with Kyun following the event are available for ERDF SMEs. Please email for the link to the recording of this event on YouTube.


Value Proposition Development and Health Economics Support (17th September)

This session was designed specifically for organisations enrolled in the ERDF-funded Research and Innovation (R&I) Health Accelerator Programme, academics, clinicians and healthcare experts. We welcomed 16 participants overall. ERDF members have direct access to expertise and bespoke support to help progress products and services towards commercialisation in the health and care system.

The interactive session was led by Dr Alexander Thompson (Research Fellow, Manchester Centre for Health Economics) and Yasmin Zobedey (Health Economist, Health Innovation Manchester), who used their experience and expertise to introduce a range of Health Economics modelling approaches and provide advice on how to develop a value proposition. We were also joined by Dr Martin Fergie, Lecturer in Health Sciences, Sonia Nikolovski from The University of Manchester Innovation Factory and the ERDF R&I Health Accelerator, and Joely Irlam, Research Associate at The University of Manchester and Director of ManTRa Diagnostics.

Please email for the link to the recording of this event on YouTube.